510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K940838Substantially Equivalent

Microvasive Ultraflex Esophageal Stent System

Boston Scientific Corporation, Watertown MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K940838 is the FDA 510(k) clearance record for MICROVASIVE ULTRAFLEX ESOPHAGEAL STENT SYSTEM, a class II device, cleared for Boston Scientific Corp on under FDA product code ESW (Prosthesis, Esophageal). FDA records list 1,110 510(k) clearances for Boston Scientific Corp, from to . As of , FDA records show no recalls naming K940838.

Clearance record

Decision date
Received
(176 days to decision)
Product code
ESW Prosthesis, Esophageal
Regulation
21 CFR 878.3610
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Boston Scientific Corp 480 Pleasant St., Watertown MA
510(k) summary
Summary
Third party review
No

Clearances, product code ESW

Trailing 12 months
1 clearance under product code ESW in the twelve months to November 2026, July 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code ESW, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20261
August 20260
September 20260
October 20260
November 20260